Clinical Performance of Chairside CAD/CAM Restorations
Primary Purpose
Dental Cements, Caries,Dental
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lithium disilicate onlays (IPS emaxCAD/Ivoclar)
Chairside zirconia crowns (3M)
Sponsored by
About this trial
This is an interventional treatment trial for Dental Cements
Eligibility Criteria
Inclusion Criteria:
- Subject in need of crown and/or onlay restoration
- Subject age 18 or above
- Subject with healthy / treated periodontal status (max. degree of movement 1)
- Subject agrees to participate in the study and signed informed consent and HIPAA form
Exclusion Criteria:
- Devital or sensitive teeth
- Teeth diagnosed with symptoms of incomplete tooth fracture
- Teeth with prior endodontic treatment of any kind
- Teeth with a history of direct or indirect pulp capping procedures
- Subjects with uncontrolled bruxism or parafunctional habits
- Subject has known allergies to any product used in this study
- Subject will not be available for the study duration
- Subjects with significant untreated dental disease to include periodontitis and rampant caries
- Pregnant or lactating women
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
CAD/CAM Onlays
CAD/CAM Crowns
Arm Description
Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with an adhesive (3M) and cement (3M).
Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M).
Outcomes
Primary Outcome Measures
Functional long-term properties clinical performance of restorations (onlays and crowns) [Change from baseline]
Evaluations according to FDI criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional properties (anatomical form, material fracture, retention, margin adaptation, occlusal contour and wear, proximal contact and contour); visual and/or tactile assessment by two independent examiners, patient interview]
Esthetic properties of restorations (onlays and crowns) [Change from baseline]
Evaluations according to FDI criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Esthetic properties (surface luster, surface staining, margin staining, color match, translucency)
Biologic properties of restorations (onlays and crowns) [Change from baseline]
Evaluations according to FDI criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Biological properties (post-operative sensitivity, recurrence of caries, erosion, abfraction); visual and/or tactile assessment by two independent examiners, patient interview]
Short-term post-operative sensitivity [Change from baseline]
Rating scale [1: No sensitivity, 2: Slight sensitivity, 3: Moderate sensitivity, 4: Severe discomfort]
Secondary Outcome Measures
Gingival index
Loe & Silness Index, 1963 [0: normal gingiva, 1: mild inflammation and no bleeding, 2: moderate inflammation and bleeding, 3: severe inflammation]
Plaque index
Silness & Loe Index, 1964 [0: plaque detectable in the gingival area, 1: plaque recognized only by running tip of probe across tooth surface at gingival crest, 2: moderate accumulation of plaque visible along gingival margin and adjacent tooth, 3: abundance of plaque visible along gingival margin and adjacent tooth]
Full Information
NCT ID
NCT04279574
First Posted
February 13, 2020
Last Updated
April 14, 2023
Sponsor
3M
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT04279574
Brief Title
Clinical Performance of Chairside CAD/CAM Restorations
Official Title
Clinical Performance of Chairside CAD/CAM Restorations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
Collaborators
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive.
Full contour zirconia crowns will be cemented using a self-adhesive resin cement.
Detailed Description
A wide variety of restorative materials are available for dental restorations. The most popular current materials include glass ceramics and full contour zirconia. Glass ceramic materials are generally preferred for their high translucency mimicking enamel-like esthetics of natural teeth and zirconia is preferred for high strength applications. Both of these materials are available for clinical treatment using chairside CAD/CAM technology.
The introduction of an induction sintering oven (SpeedFire oven/Dentsply Sirona) opened the opportunity for chairside full contour zirconia crowns by decreasing sintering times for zirconia to under 30 minutes. 3M Chairside Zirconia (3M) was marketed in 2019 and offers improved esthetics and high strength for monolithic zirconia restorations with an efficient processing time.
This investigation will be a longitudinal clinical trial to study the long-term clinical performance of CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (3M) and a resin cement (3M). Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Cements, Caries,Dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAD/CAM Onlays
Arm Type
Other
Arm Description
Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with an adhesive (3M) and cement (3M).
Arm Title
CAD/CAM Crowns
Arm Type
Other
Arm Description
Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive cement (3M).
Intervention Type
Device
Intervention Name(s)
Lithium disilicate onlays (IPS emaxCAD/Ivoclar)
Intervention Description
Restoration of posterior teeth
Intervention Type
Device
Intervention Name(s)
Chairside zirconia crowns (3M)
Intervention Description
Restoration of posterior teeth
Primary Outcome Measure Information:
Title
Functional long-term properties clinical performance of restorations (onlays and crowns) [Change from baseline]
Description
Evaluations according to FDI criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Functional properties (anatomical form, material fracture, retention, margin adaptation, occlusal contour and wear, proximal contact and contour); visual and/or tactile assessment by two independent examiners, patient interview]
Time Frame
3 years
Title
Esthetic properties of restorations (onlays and crowns) [Change from baseline]
Description
Evaluations according to FDI criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Esthetic properties (surface luster, surface staining, margin staining, color match, translucency)
Time Frame
3 years
Title
Biologic properties of restorations (onlays and crowns) [Change from baseline]
Description
Evaluations according to FDI criteria (Hickel et al., 2010) [1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor] Biological properties (post-operative sensitivity, recurrence of caries, erosion, abfraction); visual and/or tactile assessment by two independent examiners, patient interview]
Time Frame
3 years
Title
Short-term post-operative sensitivity [Change from baseline]
Description
Rating scale [1: No sensitivity, 2: Slight sensitivity, 3: Moderate sensitivity, 4: Severe discomfort]
Time Frame
up to 4 weeks after baseline
Secondary Outcome Measure Information:
Title
Gingival index
Description
Loe & Silness Index, 1963 [0: normal gingiva, 1: mild inflammation and no bleeding, 2: moderate inflammation and bleeding, 3: severe inflammation]
Time Frame
3 years
Title
Plaque index
Description
Silness & Loe Index, 1964 [0: plaque detectable in the gingival area, 1: plaque recognized only by running tip of probe across tooth surface at gingival crest, 2: moderate accumulation of plaque visible along gingival margin and adjacent tooth, 3: abundance of plaque visible along gingival margin and adjacent tooth]
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject in need of crown and/or onlay restoration
Subject age 18 or above
Subject with healthy / treated periodontal status (max. degree of movement 1)
Subject agrees to participate in the study and signed informed consent and HIPAA form
Exclusion Criteria:
Devital or sensitive teeth
Teeth diagnosed with symptoms of incomplete tooth fracture
Teeth with prior endodontic treatment of any kind
Teeth with a history of direct or indirect pulp capping procedures
Subjects with uncontrolled bruxism or parafunctional habits
Subject has known allergies to any product used in this study
Subject will not be available for the study duration
Subjects with significant untreated dental disease to include periodontitis and rampant caries
Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette Rauch
Organizational Affiliation
3M
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-1078
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20628774
Citation
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
Results Reference
background
PubMed Identifier
14158464
Citation
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
Results Reference
background
PubMed Identifier
14121956
Citation
LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
Results Reference
background
Learn more about this trial
Clinical Performance of Chairside CAD/CAM Restorations
We'll reach out to this number within 24 hrs